MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ESHEATH PLUS INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number 916ESPA

Device Problems Peeled/Delaminated (1454); Material Twisted/Bent (2981)

Patient Problems Vascular Dissection (3160); Insufficient Information (4580)

Event Date 05/06/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Device not returned.

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 29 mm sapien 3 valve in the aortic position via transfemoral approach, a tear of the iliac artery occurred.There was no tension while initially inserting the delivery system through the sheath.A split in the sheath was notice under fluoroscopy.Additionally, the sheath was kinked.Ds was advanced in sheath and the sheath straightened.The wire was exchanged and sheath and ds were both removed at the same time.Attempt to repair with covered stent was unsuccessful.The patient's pressure dropped, and cpr was initiated.Surgery to repair iliac artery followed.Patient received a fem-fem bypass to repair injury.Based on follow up the split appears to have been in the clear portion of the esheath.Based on the photo received delamination of the sheath occurred.There was no difficulty at all with the expander tool or the insertion of the sheath.The suspected root cause of the tear of the iliac artery is due to the damage in the sheath.The valve was successfully implanted.The valve did not pop out of the sheath and no valve damage was observed.The only issue the team experienced was the removal of the delivery system.The fcs initially thought the balloon was partially inflated.We pulled negative on the balloon but that did not help.

Manufacturer Narrative

Correction to sections d2 and h6.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential risks or adverse events associated with the overall thv procedure and may require intervention the sheath was not returned to edwards lifesciences for evaluation.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined during the evaluation.A review of post procedural photos showed the sheath liner was fully delaminated at the distal tip, and the sheath shaft was kinked and liner torn.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required a device history review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A lot history review was performed and revealed no additional similar complaint.A review of the complaint history from june 2021 to may 2022 revealed additional similar complaints for esheath (all models and sizes).The complaints were confirmed, but no manufacturing non-conformities that would have contributed to the reported events were identified.Available information suggested that patient and/or procedural factors may have contributed to the complaint events.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.A review of the risk management documentation was performed, and the reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaints were confirmed through evaluation of the provided imagery.There is no indication of a manufacturing no--conformance.Review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.As reported, ''the sheath was kinked.Ds was advanced in sheath and the sheath straightened''.Per evaluation of the provided imagery, the sheath shaft was kinked.It is possible that the patient's access vessel had presence of tortuosity, which may have subjected the sheath to suboptimal angles causing it to kink.However, as no relevant patient imagery or information was provided, this is unable to be determined.As delivery system withdrawal difficulty was experienced, it is possible that the delivery system may have caught on the liner near the distal tip and tore and delaminated.Any potentially applied excessive device manipulation to overcome the delivery system withdrawal difficulty may have also contributed to the liner tear and delamination.Additionally, it is possible that the presence of calcification within the patient's access vessel may have directly torn the liner through contact.However, as no relevant patient imagery or information was provided, this is unable to be determined.As such, available information suggests that procedural factors (delivery system withdrawal difficulty, excessive manipulation) may have contributed to the complaint events.However, a definitive root cause is unable to be determined at this time.In this case, the vascular dissection may be due to patient/procedural factors.Since no manufacturing non-conformances or labeling/ifu/training deficiencies were identified, no product non-conformance was confirmed, and the complaint occurrence rate did not exceed the applicable trending control limit, no corrective/preventative actions nor product risk assessment (pra) escalation are required.

• Brand Name: ESHEATH PLUS INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14856288
• MDR Text Key: 295070931
• Report Number: 2015691-2022-06446
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: 916ESPA
• Device Lot Number: 64096774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 07/20/2022
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male